Informations générales (source: ClinicalTrials.gov)
Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France. (France LILI)
Observational
French Cardiology Society (Voir sur ClinicalTrials)
novembre 2021
décembre 2027
05 avril 2025
Coronary calcified lesions will have an increasing impact in the daily practice of
coronary angioplasty, considering the epidemiological explosion of factors favoring
coronary calcifications, first of all diabetes. Moreover, calcified lesions are
underestimated in angiography and associated with an increase in angiographic
complications, as well as with a worse clinical prognosis. The usual techniques for the
preparation of calcified plaque, in particular rotary atherectomy, have a low penetration
rate in France (3% of procedures) and are associated with an increase in per-procedural
complications without clinical evidence of effectiveness4. A new device has been
developed by Schockwave Medical Inc. for the treatment of calcified lesions to facilitate
stent delivery: the C2 Shockwave Medical® Coronary Lithotripsy System (IVL), Inc. This
system uses the principle of lithotripsy to induce microfractures in the calcified plaque
prior to low-pressure balloon dilatation. The objective of the study is to evaluate the
safety and performance of the C2 Shockwave Medical® (IVL), Inc. coronary lithotripsy
system in coronary angioplasty in the general population in France.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Matthieu PERIER | 05/05/2025 07:12:10 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Clinique Pasteur - Toulouse - France | Benjamin Honton | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patient over 18 years old
- Patient affiliated to the National Health Insurance System
- Patient for whom a coronary angioplasty procedure is performed using the Shockwave
Medical C2 Coronary Lithotripsy System
- For indications of stent malexpansions, stent malexpansion must be defined by: a)
angiography: stent malexpansion >30% (QCA and/or stent magnification) b)
endocoronary OCT/IVUS imaging with MSA (Minimal Stent Area) <4.5 mm2 or a ratio of
MSA/MLA on reference segment<0.8
- Patient willing to participate in the registry
- Patient over 18 years old
- Patient affiliated to the National Health Insurance System
- Patient for whom a coronary angioplasty procedure is performed using the Shockwave
Medical C2 Coronary Lithotripsy System
- For indications of stent malexpansions, stent malexpansion must be defined by: a)
angiography: stent malexpansion >30% (QCA and/or stent magnification) b)
endocoronary OCT/IVUS imaging with MSA (Minimal Stent Area) <4.5 mm2 or a ratio of
MSA/MLA on reference segment<0.8
- Patient willing to participate in the registry
- Patient under 18 years of age
- Pregnant or breastfeeding patient
- Patient refusing to participate in the study or unable to give informed consent
(patient under guardianship, curatorship or legal guardianship)